A Study of KHK4827 in Patients With Systemic Sclerosis

NCT04368403 | Completed Phase 1

• 1 other identifier: 4827-007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis

Conditions

Systemic Sclerosis

Keywords

systemic sclerosis; brodalumab; KHK4827

Outcome Measures

Primary Outcomes (1)

• serum KHK4827 concentration

  Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.

Secondary Outcomes (1)

• Change in modified Rodnan skin score (mRSS) from baseline

  Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025.

Study Arms (1)

KHK4827

EXPERIMENTAL

Drug: KHK4827

Interventions

KHK4827 DRUG

210 mg every 2 weeks (Q2W), subcutaneous (SC) injection

KHK4827

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
• Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
• Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to \<30 at the pre-examination and who has progressing skin thickening

You may not qualify if:

• Any of the following significant concomitant diseases:
• Type 1 diabetes
• Poorly controlled type 2 diabetes (HbA1c \> 8.5%)
• Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
• Myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
• Poorly controlled hypertension (systolic pressure \> 150 mm Hg or diastolic pressure \> 90 mg Hg at screening)
• Severe chronic lung disease (%Forced Vital Capacity (FVC) \< 60% and %Diffusing capacity of lung for carbon monoxide (DLco) \< 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calculated with the LMS Method and Compared with Previous Values \[Japanese Respiratory Society\])
• Major chronic inflammatory diseases or connective tissue diseases other than scleroderma
• Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
• Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Related Publications (1)

• Fukasawa T, Yoshizaki A, Ebata S, Fukayama M, Kuzumi A, Norimatsu Y, Matsuda KM, Kotani H, Sumida H, Yoshizaki-Ogawa A, Kagebayashi H, Sato S. Interleukin-17 pathway inhibition with brodalumab in early systemic sclerosis: Analysis of a single-arm, open-label, phase 1 trial. J Am Acad Dermatol. 2023 Aug;89(2):366-369. doi: 10.1016/j.jaad.2023.02.061. Epub 2023 Mar 29. No abstract available.

  PMID: 36997069 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 29, 2020
• Study Start: October 6, 2017
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)